Aquestive Therapeutics, Inc.

Company focus

• A pharmaceutical company developing medicines that deliver complex molecules through non-invasive administration routes to replace or augment invasive standard-of-care therapies.
• Headquarters: Warren, New Jersey (corporate HQ and primary research facilities).
• Manufacturing facilities: Portage, Indiana.
• Production capacity described as sufficient for commercial quantities of licensed products and proprietary candidates in development.
• Collaborates with other pharmaceutical companies to bring new molecules to market using proprietary delivery technologies.

Core technologies

• PharmFilm® (oral film)
  • Delivers active pharmaceutical ingredients via buccal, sublingual, or lingual routes.
  • Thin, postage-stamp sized films that dissolve readily with or without water.
  • Advantages include faster or equivalent onset, ease of administration without a device, avoidance of first-pass hepatic metabolism, reduced gastrointestinal side effects, improved tolerability for patients with dysphagia or psychological barriers, and customizable pharmacokinetic profiles.
  • The company is described as a world leader in oral film drug delivery and manufacturing, having shipped over two billion doses globally.
• AdrenaVerse™ (epinephrine prodrug platform)
  • Library of more than 20 epinephrine prodrug candidates designed to control absorption and conversion across mucosal surfaces and skin.
  • Aims to enable local delivery with sustained local exposure and reduced systemic exposure.
  • Candidates include Anaphylm™ (dibutepinephrine) sublingual film and AQST-108 (epinephrine) topical gel.

Product portfolio and pipeline

Licensed commercial products (manufacturing and licensing activities)

• Suboxone® (buprenorphine/naloxone sublingual film)
  • Exclusive manufacture and supply for the U.S. and international markets; launched by licensee Indivior in 2010.
  • Historically held a dominant position in its category; about 24% film market share as generic film products entered the market.
  • Over 3.0 billion doses manufactured since 2010.
• Emylif® (riluzole oral film for ALS)
  • European development and commercialization licensed to Zambon (Emylif in EU); Aquestive handles development and manufacture.
  • Earned a $500,000 milestone in Q2 2025 under the Zambon license.
  • Exclusive U.S. manufacturing and supply arrangements for Exservan in the U.S. ended in June 2024.
• Libervant® (diazepam buccal film)
  • Approved for U.S. market access for acute treatment of seizure clusters (ARS) in children aged 2–5 years (April 2024).
  • Seven-year Orphan Drug Exclusivity (ODE) granted for ARS in that pediatric subgroup (October 2024).
  • Legal developments in 2025 (Neurelis v. FDA) affected U.S. market access for Libervant for ARS in 2–5-year-olds; FDA may pursue approvals for additional age groups or other regulatory paths.
• Sympazan® and Ondif®
  • Listed among licensed CNS and other products distributed via licensing arrangements.

Proprietary product candidates

• Anaphylm™ (dibutepinephrine) sublingual film
  • Non-device, orally delivered epinephrine prodrug in Phase 3 development for emergency treatment of allergic reactions including anaphylaxis.
  • NDA was accepted by the FDA in 2025 with a PDUFA target date of January 31, 2026. The FDA issued a Complete Response Letter on January 30, 2026 citing human factors (HF) for packaging/handling and related PK/PD considerations, and requested an HF validation study and a PK study; the company plans a resubmission in Q3 2026 with HF and PK studies running in parallel.
  • International regulatory strategies for the EU, Canada, and the UK are being pursued with submissions planned in 2026.
• AQST-108 (epinephrine topical gel)
  • Dipivefrin topical gel aimed at local delivery to skin and hair follicles, with potential application in alopecia areata.
  • IND opened in Q4 2025; a Phase 1 safety/tolerability data readout from a second Phase 1 trial was expected in Q2 2026. Development includes ongoing toxicology and preclinical work.

Financial highlights

• Revenue from licensed commercial products:
  • 2025: $44.545 million
  • 2024: $57.561 million
• Manufacturing and commercial metrics:
  • Suboxone: over 3.0 billion doses manufactured since 2010.
  • PharmFilm: shipped more than two billion doses globally.

Regulatory and strategic status

• Anaphylm NDA: accepted by FDA in 2025; PDUFA target date January 31, 2026; FDA issued a CRL on January 30, 2026 requiring HF validation and a PK study, with parallel timing recommended; resubmission planned for Q3 2026.
• International regulatory plan for Anaphylm includes EU, Canada, and UK submissions in 2026; EMA feedback indicated no further adult trials were needed and identified pediatric trial considerations.
• Libervant regulatory status is affected by court decisions and orphan drug exclusivity considerations for competing products (e.g., Valtoco); Aquestive continues discussions with the FDA about approvals for older pediatric age groups and related market access timing.
• Ongoing manufacturing and supply commitments continue for licensed products, with Aquestive serving as exclusive manufacturer for certain licensed brands.

Intellectual property and market position

• PharmFilm positions Aquestive as a leading provider of oral film drug delivery with an established manufacturing track record and extensive commercial experience with major pharmaceutical licensees.
• AdrenaVerse is a strategic platform for epinephrine prodrugs designed to extend routes of administration and broaden potential indications beyond immediate emergency use.
• The company aims to create differentiated delivery options for large markets including epinephrine therapy, CNS rescue therapies, and dermatologic indications such as alopecia areata.